Fundus Image-guided Focal Electroretinography, Usability Study

November 7, 2022 updated by: Maculaser Oy
The purpose of this study is to investigate the usability of fundus image-guided focal electroretinography device with healthy subjects and with macular edema and macular degeneration patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, we will study the usability of focal electroretinography device combined with slit lamp biomicroscope. The device allows simultaneous fundus imaging and focal ERG recording from the desired retinal area.

In phase I, the usability of the investigational device is tested with 10 healthy volunteers. The examinations include focal ERG and noise tests with commercial ERG electrodes. The stimulus lights are guided to the fundus using either non-contact of contact fundus lens. One electrode is selected for phase II based on signal-to-noise ration, usability, and comfort.

In phase II, fundus image-guided focal ERG recordings are conducted with total of 10 patients having either macular edema or macular degeneration. The aim of the phase II is to test whether the investigational device can be used to record focal ERG signal from the desired symptomatic retinal area.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00280
        • Helsinki University Hospital, Retinal Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers with no signs of macular edema or macular degeneration (phase I)
  • Patients with either macular edema or macular degeneration (phase II)
  • Able to give informed consent

Exclusion Criteria:

  • Epileptic patients
  • Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I, healthy subjects
General usability of the device is tested with healthy patients. Different commercial electroretinography electrodes are tested to investigate the patient comfort, usability and signal-to-noise ratio when recording fundus image-guided focal electroretinography with the investigational device. Most suitable electrode is selected to phase II.
Device: ERG electrode tests for fundus image-guided focal ERG
Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.
Experimental: Phase II, patients with macular edema or macular degeneration
The usability of the device is tested with patients suffering either from macular edema or macular degeneration. Fundus image-guided focal electroretinography is recorded with the electrode chosen in phase I from two different retinal areas: from an area with macular edema or signs of macular degeneration and from a healthy area (area without macular edema or signs of macular degeneration).
Device: Fundus image-guided focal ERG
Record focal ERG from a healthy retinal area and from an area with visible symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal-to-noise ratio of focal electroretinography signal
Time Frame: Through study completion, an average of 1 year
Signal-to-noise ratio of the focal ERG signals with different ERG electrodes.
Through study completion, an average of 1 year
Focal ERG from symptomatic retinal area
Time Frame: Through study completion, an average of 1 year
Explore the device feasibility in recording focal ERG signal from areas with macular edema or macular degeneration.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient comfort and usability of different ERG electrodes in focal ERG.
Time Frame: Through study completion, an average of 1 year
Investigated using a questionnaire for the subjects and investigator.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maculaser Oy

Investigators

  • Principal Investigator: Joni Turunen, MD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2021

Primary Completion (Actual)

August 25, 2022

Study Completion (Actual)

August 25, 2022

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MACULARERG01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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